FACT WORKSHOP CORD BLOOD, CELLULAR THERAPY, REGENERATIVE MEDICINE INSPECTION AND ACCREDITATION WORKSHOP

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1 FACT WORKSHOP CORD BLOOD, CELLULAR THERAPY, REGENERATIVE MEDICINE INSPECTION AND ACCREDITATION WORKSHOP WEDNESDAY 01/07/2015 Morning Parallel Sessions Cord Blood Banking Cellular Therapy/Regenerative Medicine 08:00 Theofanis Chatzistamatiou: Welcome 08:00 Andreas Papassavas: Welcome 08:15 Sue Armitage: Hot Topics in Standards Interpretation 08:15 Phyllis Warkentin: 6th Edition FACT-JACIE Standards 09:00 Korina Peste: FACT-Accreditation of Private Banks 09:00 Elizabeth J Shpall: Donor Suitability versus Donor Eligibility 09:45 Gesine Koegler: Cord Blood Unit Specifications 09:45 TBA: Common Standards for Cellular Therapies 10:30 Linda Peltier: Donor Recruitment and Evaluation 10:30 Phyllis Warkentin: Considerations for Product Exchange Between Third Parties 11:15 Efstathios Michalopoulos: Cord Blood Collection Models 11:15 TBA: Quality Management as a Bridge Between Basic Research and Translational Medicine 12:00 Lunch Joint Afternoon Session 13:00 Phyllis Warkentin: The FACT Inspection and Accreditation Process 14:00 Andreas Papassavas: Quality Management Programs 15:15 Coffee Break 15:30 Theofanis Chatzistamatiou: Maintaining Inspection Readiness 16:00 Efstathios Michalopoulos: Common Citations 16:30 Phyllis Warkentin: Mock Inspection Videos 17:00 Adjourn

2 PRELIMINARY PROGRAM THURSDAY 02/07/ :30 13:30 ADMISSIONS 13:45 14:00 Welcome Address * Symposium Chairs 14:00 14:45 Lecture I Chair: Argiris Efstratiades * Dimitris Thanos: The interplay of stochastic and deterministic mechanisms of cellular reprogramming 14:45 16:45 Plenary Session I History and Current Status of Cord Blood Banking * Catherine Stavropoulos: History of the Hellenic Cord Blood Bank 14:45 15:15 * Cristina Navarrete: Current status and future developments in cord blood banking 15:15 15:45 and transplantation * Andromachi Scaradavou: Cord Blood unit selection for unrelated transplantation 15:45 16:15 * Gesine Koegler: Cord Blood Banking 16:15 16:45 16:45 17:00 Coffee Break

3 17:00 18:30 Plenary Session II Cord Blood Transplantation in Action * Ioannis Baltadakis: Hellenic Experience of Cord Blood Transplantation in Adults 17:00 17:30 * Alexandros Spyridonidis: When the Haplo-identical donor Becomes an Option 17:30 18:00 * Elizabeth Shpall: Enhancing cord blood engraftment 18:00 18:30 18:30 19:15 Keynote speech Chairs: Catherine Stavropoulos-Giokas, Andreas Papassavas * Pablo Rubinstein: The Social Benefit of Public Cord Blood Banking 19:15 Symposium Opening Welcome Reception Chairs: Catherine Stavropoulos-Giokas, Andreas Papassavas Speakers TBA

4 FRIDAY 03/07/ :30 09:00 ADMISSIONS 08:30 10:00 Plenary Session III Management Aspects of Cord Blood Banking * Sue Armitage: Cord Blood Association 08:30 09:00 * Andreas Papassavas: Hellenic Cord Blood Bank: A Decade of Public Offer - Reflections into 09:00 09:30 the Future * Simonetta Pupella: Organization of CBBs in National Networks Under the 09:30 10:00 Competent Authorities 10:00 10:15 Coffee Break 10:15 11:45 Plenary Session IV Regulatory Issues and Accreditations * Phyllis Warkentin: The FACT Inspection and Accreditation Process 10:15 10:45 * Elisavetta Naumova: Cord Blood and HLA: Standards, Accreditation and Beyond 10:45 11:15 * Andreas Papassavas: Quality Management Programs 11:15 11:45

5 12:00 12:30 Lecture II Lecture: * Dimitris Monos: Resolving a Sixty year old problem: HLA typing by Next 12:00 12:30 Generation Sequencing 12:30 13:30 Lunch Break 13:30 15:30 Plenary Session V The Future of Cord Blood Banking * Linda Peltier: Development of Third Party Grafts from Pooled CD34-selected 13:30 14:00 Cryopreserved Cord Blood Units for Stem Cell Transplantation * Paolo Rebulla: The Italian Project on Cord Blood Platelet Gel 14:00 14:30 * Patrick Hanley: Adoptive Immunotherapy in Hematopoietic Stem Cell Transplantation 14:30 15:00 * Apostolos Stathopoulos: A personalized immunotherapeutic vaccine (Gliovac or ERC1671) 15:00 15:30 against recurrent glioblastoma multiforme (GBM) 15:30 15:45 Coffee Break

6 15:45 17:45 Plenary Session VI Regenerative Medicine and Advanced Cellular Therapies * Dominique Charron: Allogenicity and Immunomodulation of Stem Cells: Towards 15:45 16:15 Personalized Regenerative Medicine * Sotiris Korossis: From Heart to Lung and Back: Engineering the Path 16:15 16:45 * Clementine Karageorgiou: Transplantation of Mesenchymal Stem Cells: A challenge for the 16:45 17:15 Future * Michalis Iosifidis: Cell Therapy for Cartilage Lesions Treatment 17:15 17:45 17:45 18:00 Closing remarks Symposium Chairs

7 SPEAKERS AND TOPICS Keynote Speaker Rubinstein Pablo, Co Founder and Director of the National Cord Blood Program at the New York Blood Center. Director of the Fred. H. Allen Jr. Laboratory of Immunogenetics, Adjunct clinical professor at Columbia University, USA The Social Benefit of Public Cord Blood Banking Lectures Monos Dimitris, Professor of Pathology and Laboratory Medicine at the Children's Hospital of Philadelphia Dept. of Pathology and Laboratory Medicine, Pennsylvania, USA. Resolving a Sixty year old problem: HLA typing by Next Generation Sequencing Thanos Dimitris, Professor.. The interplay of stochastic and deterministic mechanisms of cellular reprogramming Plenary Sessions Armitage Sue, Assistant Director, Cord Blood Bank, Department of Stem Cell Transplantation, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, USA. Cord Blood Association

8 Baltadakis IoannisD,, Evaggelismos General Hospital, Athens, Greece. Hellenic Experience of Cord Blood Transplantation in Adults Charron Dominique, Prof. of Immunology, Director of INSERM UMRS 940. Head of the Jean Dausset Histocompatibility & Immunogenetics Laboratory, Saint Louis Hospital, Paris, France Allogenicity and Immunomodulation of Stem Cells:Towards Personalized Regenerative Medicine Cardiac stem cells biology HLA expression on stem cells Treg induction by stem cells PD1_PDL1 induced Immunoregulation NK Allogenicity Stem cells banking for regenerative medicine Hanley Patrick, Director, GMP for Immunotherapy, Assistant Professor at Children's National and GWU, Cell Therapy Expert, Speaker, Washington, District Of Columbia, USA Adoptive Immunotherapy in Hematopoietic Stem Cell Transplantation Virus-specific T cells from healthy donors Virus-specific T cells from umbilical cord blood Virus-specific T cells from CMV-seronegative adult donors Iosifidis Michalis,, Papageorgiou General Hospital, Thessaloniki, Athens Cell Therapy for Cartilage Lesions Treatment Autologous Chondrocyte Transplantation Autologous MSCs Trasplantation Bone marrow stimulation Scaffolds in cartilage lesions treatment New perspectives: allogeneic MSCs for cartilage lesions treatment Karageorgiou Klimentini, Iatriko Athinon Hospital, Athens, Greece Transplantation of Mesenchymal Stem Cells: A challenge for the Future

9 Koegler Gesine, Director of The José Carreras Cord Blood Bank and The Cell Processing Laboratory of the Institute for Transplantation Diagnostics and Cellular Therapeutics, Medical School of the University of Düsseldorf, Germany Cord Blood Banking Cord blood progenitor s and gestational age, clinical implications Impact of the way of volume reduction (HES, non HES) on cord blood quality Measurement of CD34+ 7AAD as compared to Annexin Fresh versus cryopreserved How to adapt the inventory to the demands of the market Korossis Sotiris, Lower Saxony Centre for Biomedical Engineering, Implant Research and Development, Department of Cardiothoracic, Transplantation and Vascular Surgery, Hannover Medical School, Germany From Heart to Lung and Back: Engineering the Path Heart valve tissue engineering Bioartificial Lung Tissue Decellularisation Endothelialisation In vitro testing (biological/biomechanical) Computational modelling Naumova Elisavetta,, Head of Department of Clinical Immunology, University Hospital Alexandrovska, Bulgaria Cord Blood and HLA: Standards, Accreditation and Beyond Navarrete Cristina,, Consultant Clinical Scientist, Histocompatibility and Immunogenetic Services, NHSBT & Scientific Advisor BBMR and NHS CBB, London, UK Current status and future developments in cord blood banking and transplantation Papassavas Andreas, Assistant Director, Laboratory Director, Hellenic Cord Blood Bank, Biomedical Research Foundation, Academy of Athens, Athens, Greece Hellenic Cord Blood Bank: A Decade of Public Offer - Reflections into the Future

10 Quality Management Programs Peltier Linda, Director of the Clinical Research Cord Blood Bank, Royal Victoria Hospital, Canada Development of Third Party Grafts from Pooled CD34-selected Cryopreserved Cord Bloo Units for Stem Cell Transplantation Public CBB Different CB transplantation methods Pooling methods and outcomes CB/Mother ABO Compatibility Pupella Simonetta, Responsible for Blood Safety, Italian National Blood Centre, National Institute of Health ISS, Roma, Italy Organization of CBBs in National Networks Under the Competent Authorities The regulatory framework of Cord Blood Banking in Italy Italian national requirements of Cord Blood Banking Activity data of the Italian Cord Blood Bank Network (ITCBN) Current weakness of cord blood transplantation in Italy New perspectives for a network of cord blood banks under the national health system Rebulla Paolo, Director, Centre of Transfusion Medicine, Cellular Therapy and Cryobiology, Dept. of Rege8nerating Medicine, IRCCS Ospedale Maggiore Policlinico, Italy The Italian Project on Cord Blood Platelet Gel Cord blood use for hemopoietic transplant Additional therapeutic uses of cord blood: cord blood platelet gel Potential new therapeutic uses of cord blood: cord blood eye drops Scaradavou Andromachi, Department of Pediatrics, Allogeneic Bone Marrow Transplant Service, Department of Pediatrics, Allogeneic Bone Marrow Transplant Service, New York, Medical Director National Cord Blood Program at the New York Blood Center, USA Cord Blood unit selection for unrelated transplantation Criteria for CBU selection for transplant: TNC, potency assays, HLA match (antigen/allele level) Feto-maternal interactions and effects on transplant outcomes and CBU selection Stability studies (evaluation) on older CBUs CBU segment for evaluation of quality of cryopreserved product

11 CBU selection algorithm Shpall Elizabeth, Medical Director of Cell Therapy Laboratory, Director of Cord Blood Bank, Department of Stem Cell Transplantation, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, USA Enhancing cord blood engraftment Expansion of Hematopoietic Stem Cells Homing of Hematopoietic Stem Cells Spyridonidis Alexandros,, Patras, Greece When the Haplo-identical donor Becomes an Option Stathopoulos Apostolos, Clinical Assistant Professor of Neurosurgery,Keck School of Medicine, University of Southern California U.S.A, Head of Neurosurgery Dpt., Vivalia Hospitals, Province de Luxembourg, Belgium A personalized immunotherapeutic vaccine (Gliovac or ERC1671) against recurrent glioblastoma multiforme (GBM ) Stavropoulos Giokas Catherine, Founder and Director/Medical Director of the Hellenic Cord Blood Bank, Biomedical Research Foundation, Academy of Athens, Athens, Greece History of the Hellenic Cord Blood Bank The first attempts for a Cord Blood Bank in Greece Establishment of the Hellenic Cord Blood Bank Milestones of the Hellenic Cord Blood Bank Warkentin Phyllis, Biological Production Facility Medical Director, College of Medicine, Dpt. Of Pathology and Microbiology University of Nebraska Medical Center and Foundation for the Accreditation of Cellular Therapy (FACT) Medical Director. The FACT Inspection and Accreditation Process

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